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NCT06651294 | NOT YET RECRUITING | Urolithiasis

Efficacy of Neorenal Forte for the Complete Elimination of Residual Fragments
Sponsor:

Neopharm Bulgaria Ltd.

Brief Summary:

The purpose of this study is to evaluate the efficacy of a specialized formula of phytotherapeutic extracts (Neorenal Forte) aiding the complete elimination of residual fragments after fURS in adults.

Condition or disease

Urolithiasis

Intervention/treatment

Neorenal Forte

Placebo

Phase

NA

Detailed Description:

The study is being initiated to support the informed decision making by healthcare specialists on the initiation of a specific and safe formula of phytotherapeutic extracts with duration at least three months after endourological procedures, as a routine part of urolithiasis treatment, aiding the complete elimination of residual fragments, which will allow minimizing of the short-term and long-term complications. By evaluating the percentage of complete elimination of residual fragments or fragments \< 2 mm in diameter, we aim to estimat the efficacy and safety of Neorenal Forte.

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : TRIPLE
Masking Description : Investigators will be provided with coded products which are identical in appearance. Each individual involved in the study will be blinded to the treatment assignment until study completion. Considering the established safety profile of the formula of phytotherapeutic extracts, emergency unblinding of treatment assignment will not be necessary. So no copies of the treatment assignments will be stored at the enrollment sites. No information about the subjects will be shared with the company conducting the randomization.
Primary Purpose : TREATMENT
Official Title : Efficacy and Safety of Neorenal Forte as Adjuvant Treatment for the Complete Elimination of Residual Fragments After Flexible Ureterorenoscopy With Laser Lithotripsy for Renal Calculi.
Actual Study Start Date : 2025-02-15
Estimated Primary Completion Date : 2025-12-30
Estimated Study Completion Date : 2026-03-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Male or female 18 to 65 years of age.
  • 2. The subject has signed informed consent approved by an Ethics Committee and agrees to the on-site study visits.
  • 3. A stone confirmed by NCCT of kidney, ureter and urinary bladder for assessment of size, number, location and stone density, within 90 days of fURS.
  • 4. Single or multiple kidney stones with total size of 10x10 mm to 15x10 mm.
  • 5. Stone density 751 - 1000 Hounsfield units (HU).
  • 6. Subjects post fURS for laser lithotripsy of kidney stone.
  • 7. Residual fragments \< 4 mm after fURS confirmed by ultrasound on first postoperative day.
  • 8. Subjects post one fURS.
  • 9. fURS uncomplicated by perforation of ureter, mucosal exfoliation, damage to kidney or urinary bladder, serious bleeding or other complications.
  • 10. No recent ureterorenoscopy within the last 6 months.
  • 11. Body mass index 17.0 - 29.99 kg/m2 118
  • 12. In Investigator's opinion, the subject can comply with the visit schedule and the treatment regimen and is capable of completing the study.
  • 13. The subject has a smartphone and is capable of using it.
Exclusion Criteria
  • 1. Subjects with anatomical anomalies revealed by ultrasound - stenosis of the pyelo-ureteral junction, horseshoe kidney, kidney malrotation, calyceal diverticulum, and others.
  • 2. Ureteral stenosis.
  • 3. History of ipsilateral renal surgery.
  • 4. Hydronephrosis.
  • 5. Permanent JJ stent.
  • 6. Any conditional or absolute contraindications for fURS.
  • 7. Combined ipsilateral stone in the ureter or contralateral stone in the upper urinary canal or a stone in the lower urinary canal, requiring simultaneous surgery.
  • 8. Subjects with positive urine culture, until resolution.
  • 9. History of endourological intervention (e.g. nephrostoma, ureteral catheter) before fURS.
  • 10. Stone density \<750 and \>1001 HU;
  • 11. Uncontrolled diabetes mellitus (HbA1c \>9%).
  • 12. Renal insufficiency.
  • 13. Subjects with arterial hypertension.
  • 14. Subjects with benign prostate hypertrophy.
  • 15. Subjects with prostate adenoma.
  • 16. Allergy or hypersensitivity to any of the ingredients of the investigational product.
  • 17. BMI ≥ 30 kg/m2.
  • 18. Women who are pregnant or lactating; women who plan on getting pregnant during the study.
  • 19. Alcohol or drug abuse in the last year.
  • 20. Unstable medical conditions, as determined by the Investigator.
  • 21. Inability to comply with the study protocol.
  • 22. Subjects who cannot understand or not capable of completing the study documents.
  • 23. Inability to give informed consent.
Efficacy of Neorenal Forte for the Complete Elimination of Residual Fragments

Location Details

NCT06651294

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